To better meet a medication safety paradigm established during a consensus conference convened in 2010 by the Anesthesia Patient Safety Foundation (APSF), hospital researchers conducted a medication safety study in three pharmacy satellites and in 78 areas of care where anesthetic agents were used. The primary focus of the study was to look at labeling compliance, medication preparation details and waste data during the first surgical cases of the day, with an eye toward resolving any significant safety gaps found, explained Rachel Stratman, PharmD, the lead study author and a clinical pharmacist for perioperative services at Barnes-Jewish Hospital.

After collecting initial data for 100 cases, Dr. Stratman and her colleagues found several problems that could have led to patient harm. For example, anesthesia providers often would prescribe, prepare and administer medications with no double-check, and providers usually would include only partial information on the blank portions of syringe labels, such as the drug name, but not necessarily other important details, such as drug concentration or expiration date. Moreover, anesthesiologists often would prepare medicines such as atropine for emergent situations; however, if the drugs were not administered during the case, they were discarded or inappropriately kept beyond their expiration for use on subsequent cases.

Ready-to-use medications

Based on those findings, Dr. Stratman’s team made several improvements to the handling processes for anesthesia medications. One step, she noted, was to standardize anesthesia medication trays across 64 ORs and 14 remote areas. The trays incorporated ready-to-use syringes of medications commonly used for anesthesia induction, reversal and emergencies. The quality improvement team also standardized vasoactive drip concentrations and diluents across the institution, and increased production of compounded sterile products dispensed to anesthesiologists upon request.

The pharmacy purchased premixed ready-to-use syringes of eight commonly used medications, including lidocaine, succinylcholine and neostigmine, from a compounding pharmacy.The department also boosted the production of vasoactive drips such as epinephrine and dobutamine, and provided bolus doses of drugs such as insulin, epinephrine and norepinephrine. The ready-to-use, prefilled syringes had tamper-evident seals, so if they were not used for one patient, they could be used safely for another patient.

Six months after the intervention, the team observed the medication management practices of 100 additional cases. They found that the rate at which the medication concentration was included on the label increased significantly, from 31% before the intervention to nearly 78% after (P<0.001). The percentage of provider-prepared IV admixtures was reduced from 91% to nearly 3% (P<0.001).

Using ready-to-use medications also
significantly reduced medication waste, Dr. Stratman said. The largest reductions noted were for emergency medications such as atropine and phenylephrine (96% reduction) and succinylcholine (nearly 95% reduction).

Dr. Stratman said she estimates the intervention has been “cost neutral” to the hospital, with the costs of outsourcing medications partially offset by the savings in otherwise wasted medicines (Table). “But when you look at the [impact of the initiative on] quality and safety for the patients … it’s what’s right to do even if it costs a little more.” She added that the safety initiative “has been very successful from the anesthesiology perspective and the pharmacy perspective.”

Table. Cost of Medication Wastea

Medication

Pre-Outsourcing

Post-Outsourcing

Mg Reduction

Waste

Cost b

Waste

Cost b

Lidocaine

3,200 mg

$87.36

300 mg

$10.56

90.6%

Rocuronium

2,250 mg

$176.91

200 mg

$22.32

91.1%

Succinylcholine

9,600 mg

$132.96

500 mg

$26.15

94.8%

Vecuronium

80 mg

$37.12

30 mg

$22.38

62.5%

Glycopyrrolate

10 mg

$13.80

1 mg

$4.61

90%

Phenylephrine

77.6 mg

$79.15

3 mg

$11.40

96.1%

Atropine

55 mg

$127.68

2 mg

$6.22

96.4%

a Waste isdefined as withdrawal of medication from the manufacturer’s packaging or removal of tamper-evident seal but not documented as administered during the surgical case.

b $1 added to the hospital cost of the vial to account for cost of preparation, labor and supplies.

Outsourcing ready-to-use medications is a trend, Dr. Stratman said, although “the financial impact associated with outsourcing costs can cause institutions to hold off on making the transition…. In our hospital, it has been instrumental in improving the management of medications in the anesthesia environment.”

Avoid Do-It-Yourself Drug Prep

Tricia Meyer, PharmD, FASHP, the director of pharmacy at Scott & White Healthcare, in Temple, Texas, and an assistant professor of anesthesiology at Texas A&M University College of Medicine, in College Station, participated in the APSF Medication Safety Conference. She said the APSF recommends that provider-prepared medications should be discontinued whenever possible in favor of providing prefilled syringes for anesthesia care providers.

“Prefilled syringes save time for anesthesiologists, allowing that time to be utilized for necessary monitoring of the patient and the anesthesia equipment,” she said. “That’s why it’s important, but there’s a premium price [to be paid] for purchased, prefilled syringes. When you buy from a compounding pharmacy, you have to pay not only for the drug but for the preparation time, as expected.”

In the wake of the Massachusetts compounding crisis, however, vetting vendors can be a risky proposition (see sidebar, “Are Outside Compounders Safe?,” page 13). Still, Dr. Meyer said she supports flexibility—that is, using prefilled syringes drawn up by the hospital pharmacy, or purchased when possible and when budgets or staffing resources allow.

As for the strategy employed at Barnes-Jewish, “their project results were impressive,” Dr. Meyer said. “The ability to document cost neutrality is important for other hospital pharmacies to consider and possibly use to help justify use of prefilled syringes.”

For those concerned with costs, she said, evaluate what drugs are most consistently used and/or frequently wasted and begin with a minimal number of medications in prefilled syringes.

The issue of waste in the OR setting is important, she stressed. Many times, anesthesia care providers may predraw syringes waiting for emergent cases, and the predrawn syringes need to be destroyed within an hour if they’re unused. The Barnes-Jewish researchers “were able to determine the cost of waste, which is not easy, and use the amount saved with their new process to justify the cost of the prefilled syringes,” she said. “That’s strong work.”

Managing the prefilled or premixed medications “does take more vigilance on the part of pharmacists because of shorter beyond-use dating,” Dr. Meyer said. Premixed syringes may have expiration dating of 30 to 90 days, whereas a vial from the manufacturer can last much longer. As a result, she noted, pharmacy staffers need to check inventory for expirations more frequently.

Are Outside Compounders Safe?

Purchasing premixed, ready-to-use syringes can be a boon to time-strapped pharmacy and anesthesia deparments. But the strategy comes with a heightened risk, based on the continuing fallout from a fungal meningitis outbreak last fall that has been tied to contaminated epidural steroid injections prepared by the New England Compounding Center (NECC), in Massachusetts (see related article, page 1). As of Feb. 4, 696 patients in 20 states reported cases of fungal infection including meningitis; 45 of those patients died. Massachusetts regulators last fall found problems at five other compounding pharmacies, including Ameridose, owned by the same parent as NECC. (In December, NECC filed for bankruptcy.) At press time, several additional compounders had been cited by officials for serious safety lapses.

Before these developments, “I would have assumed that the label reflected the drug and that it was sterile,” said Robert Johnstone, MD, a professor of anesthesiology at West Virginia University, in Morgantown. “Now that really has me concerned.”

Dr. Johnstone said pharmacists and anesthesiologists at his hospital have since been trying to do more of their own compounding—a process that itself is not free of risk—and the pharmacy purchasing team has gone back to relying on major suppliers for their drug shipments. Shutdowns at NECC and other compounders also have led to a series of “rotating, unpredictable shortages” of some anesthetics, he said. In fact, “two days out of every week now, I’m dealing with some shortage and substituting a drug that isn’t as effective in order to get the anesthetic [case] done.”

Dr. Meyer said that the goal at her hospital now “is to try to do as much compounding as possible in-house” and cut back on outsourcing. The NECC event has “cast a shadow of doubt in many pharmacists’ minds about how we should select a compounder,” she said. One can have checklists, interview companies and conduct site visits to observe processes, Dr. Meyer added, but it’s difficult to ensure that the process observed one day is maintained every day.